A Study of V503 in Preadolescents and Adolescents (V503-002) - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00943722

Purpose

This study will evaluate the immunogenicity and tolerability of V503 in preadolescent and adolescent subjects between 9 and 15 years old and demonstrate the consistency of the manufactured vaccine through assessment of 3 different final manufacturing process lots of V503.

Condition	Intervention	Phase
Cervical Cancers Vulvar Cancer Vaginal Cancer Genital Lesions PAP Test Abnormalities HPV Infections	Biological: V503	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	A Phase III Clinical Trial to Study the Immunogenicity, Tolerability, and Manufacturing Consistency of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (9 to 15 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer Vaginal Cancer Vulvar Cancer

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Number of subjects with injection site adverse experiences [ Time Frame: Day 1 to 5 post-vaccination ] [ Designated as safety issue: Yes ]
Number of subjects with elevated temperature [ Time Frame: Day 1 to 5 post-vaccination ] [ Designated as safety issue: Yes ]
Number of subjects with systemic adverse experiences [ Time Frame: Day 1 to 5 post-vaccination ] [ Designated as safety issue: Yes ]
Geometric mean titers (GMTs) to each of the HPV types contained in the vaccine [ Time Frame: 4 weeks post dose 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Seroconversion percentages to each of the HPV types contained in the vaccine [ Time Frame: 4 weeks post dose 3 ] [ Designated as safety issue: No ]

Estimated Enrollment:	2800
Study Start Date:	August 2009
Estimated Study Completion Date:	April 2013
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Boys 9 to 15 years old	Biological: V503 Multivalent HPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
Experimental: 2 Young women 16 to 26 years old	Biological: V503 Multivalent HPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
Experimental: 3 Girls 9 to 15 years old - Vaccine Lot 1	Biological: V503 Multivalent HPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
Experimental: 4 Girls 9 to 15 years old - Vaccine Lot 2	Biological: V503 Multivalent HPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
Experimental: 5 Girls 9 to 15 years old - Vaccine Lot 3	Biological: V503 Multivalent HPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.

Detailed Description:

The base study V503-002 (NCT00943722) is a 12-month study that is collecting safety and immunogenicity information for six months following the subjects' third dose of study vaccine and is expected to conclude in 2011. An optional extension study (V503-002-10) (NCT00943722) will collect safety and immunogenicity information through Month 36. No study vaccine will be administered in the extension study. Subjects enrolled in the 16- to 26-year-old cohort will not be included in the study extension.

Eligibility

Ages Eligible for Study:	9 Years to 26 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Boys and Girls Age 9 to 15:

Subject is not sexually active

Women Age 16 to 26:

Subject has never had Pap testing or has had only normal results
Subject has had 0 to 4 sexual partners at the time of enrollment

Exclusion Criteria:

Boys and Girls Age 9 to 15:

History of allergic reaction that required medical intervention
Currently enrolled in any other clinical study
Subject is pregnant
Subject is immunocompromised or has taken immunosuppressants in the last year
Subject has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial
Subject has a history of positive test for HPV

Women Age 16 to 26:

History of allergic reaction that required medical intervention
Currently enrolled in any other clinical study
Subject is pregnant
Subject is immunocompromised or has taken immunosuppressants in the last year
Subject has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial
Subject has a history of positive test for HPV
Subject has a history of abnormal cervical biopsy result
Subject has a history of external genital lesions

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Vice President, Late State Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00943722 History of Changes
Other Study ID Numbers:	2009_611, V503-002
Study First Received:	July 21, 2009
Last Updated:	May 18, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Congenital Abnormalities
Uterine Cervical Neoplasms
Vaginal Neoplasms
Vulvar Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms

Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Vaginal Diseases
Vulvar Diseases

ClinicalTrials.gov processed this record on February 09, 2012